CN1315471C - Basis-reinforcing eyesight-improving dropping pill for treating eye disease and its preparing method - Google Patents
Basis-reinforcing eyesight-improving dropping pill for treating eye disease and its preparing method Download PDFInfo
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- CN1315471C CN1315471C CNB2005100766261A CN200510076626A CN1315471C CN 1315471 C CN1315471 C CN 1315471C CN B2005100766261 A CNB2005100766261 A CN B2005100766261A CN 200510076626 A CN200510076626 A CN 200510076626A CN 1315471 C CN1315471 C CN 1315471C
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Abstract
The present invention discloses a medicine composition which has the functions of adjusting evacuation qi and improving eyesight, and is used for treating dim vision, red and dry eyes, etc. caused by evacuation qi. The present invention aims to overcome the disadvantages of the existing oral medical preparations for treating the disease symptoms, and provide a basis-reinforcing eyesight-improving drop pill in an oral taking type, which has the advantages of high biologic utilization, quick medicine dilution, quick effect, high medicine content, convenient taking, low cost and no pollution in production. The basis-reinforcing eyesight-improving drop pill is prepared by the way that a mixture containing active components of six kinds of traditional Chinese medicines, such as safflower, medicine terminalia fruit, corydalis impatien, clove, borneol and bear bile powder is used as a raw material, and the raw material is mixed with a medicinal carrier used as a base material.
Description
Technical field
The present invention relates to a kind of routed gas of adjusting that has, function of improving eyesight, be used for the fuzzy viewing that routed gas causes, the pharmaceutical composition of treatment for diseases such as conjunctival congestion is dry and astringent is a kind of drug composition oral preparation that feedstock production forms with the mixture that contains 6 flavor active ingredient of Chinese herbs such as Flos Carthami, Fructus Chebulae, the purple Dong in the north to the Great Wall, Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder particularly.
Background technology
The basis-reinforcing eyesight-improving granule that is prepared from according to the preparation method that provides among the national drug standards WS-10485 (ZD-0485)-2002, be a kind of routed gas of adjusting that has, function of improving eyesight, be used for the fuzzy viewing that routed gas causes, the oral granular formulation of treatment for diseases such as conjunctival congestion is dry and astringent, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be prescription and technology and the brief description that provides among the drug standard WS-10485 (ZD-0485)-2002:
Prescription: Flos Carthami 364g, Fructus Chebulae 364g, the purple Dong 121g in the north to the Great Wall, Flos Caryophylli 364g, Borneolum Syntheticum 9.7g, Fel Ursi powder 9.7g, sucrose 430g;
Method for making: above Six-element, an amount of dissolve with ethanol of Borneolum Syntheticum, Fel Ursi powder filters filtrate for later use.Flos Caryophylli, Flos Carthami extract volatile oil, aqueous solution after distillation device is in addition collected: medicinal residues and Fructus Chebulae, Corydalis impatiens (Pall.) Fisch. decoct with water secondary, and 4 hours for the first time, 3 hours for the second time, collecting decoction, filter, it is 1.20～1.25 clear paste that filtrate is condensed into relative density, adds equivalent ethanol and makes precipitation, quiet amount 24 hours, filter, filtrate recycling ethanol is concentrated into relative density and is 1.30～1.35 thick paste.Granulate, drying sprays into above-mentioned volatile oil such as Borneolum Syntheticum, Fel Ursi powder and Flos Caryophylli with dissolve with ethanol, mixing, promptly.
Function cures mainly: regulate the gas of bursting, make eye bright.Be used for the fuzzy viewing that routed gas causes, conjunctival congestion is dry and astringent.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.The medicament contg of granule is also lower, takes inconvenience.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish the existing fuzzy viewing that routed gas causes that is used for, the deficiency of the oral drug preparation of treatment for diseases such as conjunctival congestion is dry and astringent, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations basis-reinforcing eyesight-improving dropping pill.Basis-reinforcing eyesight-improving dropping pill involved in the present invention is a raw material with the mixture that contains active ingredient of Chinese herbs such as Flos Carthami, Fructus Chebulae, Corydalis impatiens (Pall.) Fisch., Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain basis-reinforcing eyesight-improving dropping pill involved in the present invention:
[preparation method]
1. raw material: the hybrid medicine raw material that contains 6 flavor active ingredient of Chinese herbs such as Flos Carthami, Fructus Chebulae, the purple Dong in the north to the Great Wall, Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing hybrid medicine raw material and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing hybrid medicine raw material and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of hybrid medicine raw material and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil:
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of preparation method of hybrid medicine raw material]
Get Flos Carthami 364g, Fructus Chebulae 364g, the purple Dong 121g in the north to the Great Wall, Flos Caryophylli 364g, Borneolum Syntheticum 9.7g, Fel Ursi powder 9.7g, above Six-element, an amount of dissolve with ethanol of Borneolum Syntheticum, Fel Ursi powder filters filtrate for later use; Flos Caryophylli, Flos Carthami extract volatile oil, and be standby; Aqueous solution after distillation device is in addition collected; Medicinal residues and Fructus Chebulae, Corydalis impatiens (Pall.) Fisch. decoct with water secondary, and 4 hours for the first time, 3 hours for the second time, collecting decoction filters, and it is 1.20～1.25 clear paste that filtrate is condensed into relative density, add equivalent ethanol and make precipitation, left standstill 24 hours, filter, filtrate recycling ethanol, concentrated, dry, be ground into dry powder, spray into above-mentioned volatile oil such as Borneolum Syntheticum, Fel Ursi powder and Flos Caryophylli with dissolve with ethanol, mixing, promptly.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
[beneficial effect]
The basis-reinforcing eyesight-improving granule that is prepared from according to the preparation method that provides among the national drug standards WS-10485 (ZD-0485)-2002, be a kind of routed gas of adjusting that has, function of improving eyesight, be used for the fuzzy viewing that routed gas causes, the oral granular formulation of treatment for diseases such as conjunctival congestion is dry and astringent, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.The medicament contg of granule is also lower, takes inconvenience.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Basis-reinforcing eyesight-improving dropping pill involved in the present invention is compared with the basis-reinforcing eyesight-improving granule has following beneficial effect:
1. basis-reinforcing eyesight-improving dropping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the mixture that contains Flos Carthami, Fructus Chebulae, the purple Dong in the north to the Great Wall, Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder Chinese medicine active pharmaceutical ingredient; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. basis-reinforcing eyesight-improving dropping pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. basis-reinforcing eyesight-improving dropping pill involved in the present invention mixes the mixture that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of basis-reinforcing eyesight-improving dropping pill of the present invention.
[first group: the test of single-matrix]
1. raw material: it is standby to make the mixture dry powder that contains Flos Carthami, Fructus Chebulae, Corydalis impatiens (Pall.) Fisch., Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder Chinese medicine active pharmaceutical ingredient earlier according to [appendix];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the basis-reinforcing eyesight-improving dropping pill of different size.
[result of the test]
Test 1: for observe hybrid medicine raw material and different substrates when 1: 1 the proportioning prepared basis-reinforcing eyesight-improving dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe hybrid medicine raw material and different substrates when 1: 3 the proportioning prepared basis-reinforcing eyesight-improving dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe hybrid medicine raw material and different substrates when 1: 9 the proportioning prepared basis-reinforcing eyesight-improving dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: it is standby to make the mixture dry powder that contains Flos Carthami, Fructus Chebulae, the purple Dong in the north to the Great Wall, Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder Chinese medicine active pharmaceutical ingredient earlier according to [appendix];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the basis-reinforcing eyesight-improving dropping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared basis-reinforcing eyesight-improving dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 64 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 81 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 82 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 62 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 72 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 62 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 60 | ＞30 | ＞10 | + |
| Lac | 50.0 | 60 | ＞30 | ＞10 | + |
The group practices of table 2 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 70 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 75 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 86 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 73 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 71 | ＞30 | ＞10 | +++ |
The group practices of table 3 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 83 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 73 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 86 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 78 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 78 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 74 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 72 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 4 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 77 | ＜30 | ＞10 | + |
The group practices of table 5 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
The group practices of table 7 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | ++ |
The group practices of table 8 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 10 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＞10 | +++ |
The group practices of table 11 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 86 | ＜30 | ＜10 | +++ |
The group practices of table 12 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 89 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of medicinal mixture and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of medicinal mixture and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of medicinal mixture and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. one kind is used for the treatment of fuzzy viewing, the dry and astringent basis-reinforcing eyesight-improving dropping pill of conjunctival congestion, is raw material with Flos Carthami, Fructus Chebulae, the purple Jin in the north to the Great Wall, Flos Caryophylli, Borneolum Syntheticum, Fel Ursi powder, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) get Flos Carthami 364g, Fructus Chebulae 364g, the purple Jin 121g in the north to the Great Wall, Flos Caryophylli 364g, Borneolum Syntheticum 9.7g, Fel Ursi powder 9.7g, above Six-element, an amount of dissolve with ethanol of Borneolum Syntheticum, Fel Ursi powder filters filtrate for later use; Flos Caryophylli, Flos Carthami extract volatile oil, and be standby; Aqueous solution after distillation device is in addition collected; Medicinal residues and Fructus Chebulae, Corydalis impatiens (Pall.) Fisch. decoct with water secondary, and 4 hours for the first time, 3 hours for the second time, collecting decoction filters, and it is 1.20～1.25 clear paste that filtrate is condensed into relative density, add equivalent ethanol and make precipitation, left standstill 24 hours, filter, filtrate recycling ethanol, concentrated, dry, be ground into dry powder, spray into above-mentioned volatile oil such as Borneolum Syntheticum, Fel Ursi powder and Flos Caryophylli with dissolve with ethanol, mixing promptly gets the extract that contains pharmaceutically active ingredient in the above-mentioned Six-element, and is standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is that the ratio of 1: 1～1: 10 described extract and substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) treating that dropping-pill machine head and condensing agent are stable respectively and reach described state of temperature, will contain the fused solution of described extract and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splash in the condensing agent, and shrink and be shaped, promptly.
2. basis-reinforcing eyesight-improving dropping pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| 上海科技出版社 范碧亭等，中药药剂学 1997 * |
| 国家药品监督管理局国家中成药标准汇编中成药地方标准上升国家标准部分内科耳鼻喉科、眼科、皮肤科分册"固本明目颗粒" 2002;上海科技出版社 范碧亭等，中药药剂学 1997 * |
| 国家药品监督管理局国家中成药标准汇编中成药地方标准上升国家标准部分内科耳鼻喉科、眼科、皮肤科分册"固本明目颗粒" 2002 * |
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